Axelopran for Cancer
(AxeCan Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The primary objective of this single arm, open label, phase II trial is to determine if axelopran use impacts cancer control in patients with advanced cancers of the lung, breast, pancreas, and prostate. The primary study period for assessing the primary aim is through day 43 (6 weeks). The main questions it aims to answer are:
* Does axelopran show a signal for efficacy in slowing tumor progression?
* Is axelopran safe and tolerable for long-term use in this patient population?
* Does axelopran show a signal for efficacy in improving bowel function and quality of life?
* Does axelopran show a signal for efficacy in reducing systemic inflammation, cachexia, and prognostic serum biomarkers of inflammation?
Patients will take axelopran as monotherapy after relapse or progression on or after standard systemic therapy. Clinician and patient must be willing to attempt a delay in next line of systemic cancer therapy (if available) until day 43 to assess change in cancer status on repeat imaging. Clinician can move to the next line of therapy whenever deemed clinically necessary.
Participants will:
* take oral axelopran capsules daily for up to 1 year, or longer if deriving benefit
* attend 10 in-person study visits, each lasting approximately 1-2 hours
* complete study procedures including but not limited to imaging exams, blood draws, electronic health surveys, and physical assessments
Who Is on the Research Team?
Dylan Zylla, MD, MS
Principal Investigator
HealthPartners Institute Cancer Research Center
Are You a Good Fit for This Trial?
Adults with advanced prostate, breast, lung (NSCLC), or pancreatic cancer that has worsened after standard treatment can join. They must have a life expectancy of at least 2 months, be on opioid pain medication, and have at least one measurable tumor. Specific conditions apply for each cancer type regarding prior treatments received.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take oral axelopran capsules daily for up to 1 year, with primary assessment at 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term treatment
Participants may continue axelopran treatment beyond 1 year if deriving benefit
What Are the Treatments Tested in This Trial?
Interventions
- Axelopran
Trial Overview
The trial is testing axelopran's effectiveness in slowing tumor growth, improving bowel function and quality of life, reducing inflammation and cachexia (wasting syndrome), and lowering certain blood markers. Participants will take axelopran daily for up to a year or more if beneficial.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
axelopran capsules administered daily as monotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
HealthPartners Institute
Lead Sponsor
Glycyx MOR Inc.
Industry Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.